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Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: A 7-day randomized, double-blind, placebo-controlled exploratory study

International Clinical Psychopharmacology Oct 07, 2020

Rancans E, Zambori J, Dalsgaard M, et al. - Researchers investigated if it was possible to accelerate the onset of antidepressant effectiveness with a single-dose of intravenous (IV) vortioxetine at the initiation of oral vortioxetine treatment in this 7-day randomized, double-blind, placebo-controlled fixed-dose study. One dose of single-blind IV placebo (1-day placebo lead-in period) was provided to patients aged 18–65 years who were hospitalized per standard-of-care for major depressive disorder currently treated with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor for a major depressive episode (Montgomery–Åsberg Depression Rating Scale total score ≥ 30), before randomly switching them to either single-dose IV vortioxetine 25 mg plus daily oral vortioxetine 10 mg (n = 39), or IV placebo plus daily oral placebo (n = 41). Per pharmacokinetic data, IV vortioxetine facilitated attaining steady-state plasma concentration within 24 hours. Participants tolerated IV plus oral vortioxetine well, with low levels of nausea as the most common adverse event. However, there was no difference in the early antidepressant effect of a single initial IV dose of vortioxetine added to daily oral treatment vs placebo at any timepoint during a 7-day treatment period.

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